On Amendments And Additions To The Federal Act "on State Regulation In The Field Of Genetic Engineering Activity"

Original Language Title: О внесении изменений и дополнений в Федеральный закон "О государственном регулировании в области генно-инженерной деятельности"

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RUSSIAN FEDERATION FEDERAL LAW on amendments and additions to the Federal Act "on State regulation in the field of genetic engineering activity" adopted by the State Duma on June 21, 2000 year approved by the Federation Council June 28, 2000 year Article 1. To amend the Federal law dated July 5, 1996 N 86-FZ "on State regulation in the field of genetic engineering activity" (collection of laws of the Russian Federation, 1996, no. 28, art. 3348) the following amendments and supplements: 1. Article 1, after the words "of his organism" shall be supplemented with the words "with the exception of Homo-and gene therapy (gene therapy).
2. Article 2 shall be amended as follows: "article 2. Basic concepts Basic concepts used in the present Federal law: genetic engineering-a set of practices and technologies, including technologies for producing recombinant ribonukleinovykh and dezoksiribonukleinovyh acids, to allocate the genes of an organism, the implementation of genetic manipulation and to introduce them to other organisms;
gene therapy (gene therapy)-a set of genetically engineered (biotech) and medical techniques aimed at making changes in the genetic apparatus of somatic human cells in order to treat diseases;
genetic-engineering activities-activities carried out using techniques of genetic engineering and genetically modified organisms;
gene diagnostics-a set of methods for detection of changes in the structure of a genome;
genetically modified organism-organism or a few organisms, any non-cellular, odnokletochnoe or multi cell education, capable to reproduce or transfer of hereditary genetic material differ from natural organisms obtained by genetic engineering techniques and contain genno-ingenernyi material, including genes, their fragments or combinations of genes;
the release of genetically modified organisms into the environment Wednesday-the Act or omission occurred which resulted in the introduction of genetically modified organisms into the environment Wednesday (this concept does not apply to activities related to changing human genetic material inherited through the use of techniques of genetic engineering for the purpose of gene therapy (gene therapy);
biological protection-create and use genetic engineering safe for humans and the environment object Wednesday combination of biological material whose properties foreclose an undesirable survival of genetically modified organisms into the environment Wednesday and (or) the transfer of genetic information;
physical protection-the creation and use of special technical means and techniques to prevent the release of genetically modified organisms into the environment Wednesday and (or) their transfer of genetic information;
clinical trials-testing the effectiveness and safety of gene therapy (gene therapy);
closed system-system of genetic engineering activity in which genetic modifications are made to the organism or genetically-modified organisms cultivated, processed, stored, used, transported or destroyed were subjected to dumping in the face of physical, chemical and biological barriers, or combinations of them, preventing contact of genetically modified organisms and the environment Wednesday;
Open system-system of genetic engineering activity involving contact of genetically modified organisms and the environment Wednesday when their deliberate release into the environment Wednesday, applying for medical and nutritional purposes, exports and imports, with the transfer of technology;
transgenic organisms-animals, plants, microorganisms, viruses, genetic program which changed using techniques of genetic engineering. "
3. The second part of article 5 to complement the new third subparagraph to read: "the safety of clinical trial methods of Homo-and gene therapy (gene therapy) at the level of somatic cells;".
4. Article 6 supplemented by new third subparagraph to read as follows: "genetic manipulation at the molecular, cellular levels involving Recombinant ribonukleinovykh and dezoksiribonukleinovyh acids for purposes of Homo-and gene therapy (gene therapy) in relation to the person;".
Article 2. This federal law shall enter into force on the day of its official publication.
The President of the Russian Federation v. Putin Kremlin, Moscow July 12, 2000 N 96-FZ